Resectable Pancreatic Ductal AdenocarcinomaPhase 2Metformin 001NCT02978547
The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Metformin Hydrochloride 500Mg Tablet in people with Resectable Pancreatic Ductal Adenocarcinoma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of 7 days, until 2 days prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Metformin Hydrochloride 500Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2019to Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years on the day of study consent
- Pathologic diagnosis of PDAC where 2 pre-treatment core biopsy samples are available for analysis. Patients with suspected PDAC without a pathologic diagnosis must undergo confirmatory biopsy under endoscopic ultrasound guidance.
- Resectable disease based on standard imaging criteria
- Surgery planned ≥ 2 weeks after study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hematologic, renal, and hepatic function as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
Show all 19Show fewer
- Total bilirubin < 1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the ULN
- Lipase < 1.5 times the ULN
- Serum creatinine < 1.5 times the ULN
- Glomerular filtration rate > 30 mL/min/1.73 m2 according to the modified diet in renal disease abbreviated formula
- International normalized ratio (INR) or prothrombin time (PT; PT-INR) and partial thromboplastin time (PTT) < 1.5 times the ULN
- Platelet count > 100000 /mm3, hemoglobin (> 9 g/dL, absolute neutrophil count > 1500/mm3.
- Baseline fasting glucose <13.9 mmol/L
- No prior chemotherapy or radiotherapy for PDAC
- Serum lactate levels within normal range assessed within 7 days prior to the initiation of study treatment
- MRI sub-study:
- Signed informed consent for the optional MRI substudy
- No contraindications to MRI
Who cannot join
- Presence of locally unresectable disease or distant metastases
- Treatment with metformin or any other anti-hyperglycemic agent within the previous 6 months
- Known allergy or contraindication to metformin
- Not fit for surgery
- Planned for, or received, neoadjuvant treatment of any type
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of 7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery.
At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases 3, 8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western blot analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq analysis. Pre-metformin biopsy samples will be retrieved for molecular analysis.
Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin levels. Plasma and whole blood will also be processed and banked for circulating tumour DNA analysis. Urine samples will be sent for metabolomic profiling.
- Being tested
- Metformin Hydrochloride 500Mg Tablet
- Keywords
- Resectable pancreatic ductal adenocarcinoma, PDAC, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 500Mg TabletDrug
In the event of any grade 2 toxicities (with the exception of hyperglycemia), metformin will be withheld until improvement to ≤ grade 1, then restarted at a dose of 500 mg daily. In the event of grade ≥ 3 toxicities related to metformin, treatment will be discontinued. Metformin therapy will also be discontinued if serum lactate levels are above normal values.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | All patients will receive metformin 500 mg per oral twice daily with food for at least 7 days, until 2 days prior to surgery. Metformin therapy should be discontinued 2 days before surgery to reduce the risk of lactic acidosis associated with fasting. Receives: Drug: Metformin Hydrochloride 500Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of neoadjuvant metformin treatment on tumour cell proliferation in PDAC tumours
Assessment of Ki-67 fraction as assessed by IHC of pre- and post-metformin tumour samples.
Measured: 6 months
Secondary outcomes (10)
R0 resection rates in patients undergoing curative PDAC resection
Proportion of patients with R0 resections.
Measured: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting GGT (mmol/L)
The marker of glucose and insulin metabolism will be reported with pre- and post-metformin values compared.
Measured: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting glucose (mmol/L)
The marker of glucose and insulin metabolism will be reported with pre- and post-metformin values compared.
Measured: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting insulin (mU/L)
The marker of glucose and insulin metabolism will be reported with pre- and post-metformin values compared.
Measured: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index
HOMA index is calculated from serum glucose and insulin. The marker of glucose and insulin metabolism will be reported with pre- and post-metformin values compared.
Measured: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)
The clinical marker will be reported with pre- and post-metformin values compared.
Measured: 6 months
The effect of metformin on metabolomic profile of pre- and post-metformin samples
Serum and urine metabolomic profile.
Comparison of metabolite levels in pre-and post-metformin samples.
Measured: 6 months
Transcriptome sequencing (RNAseq) of pre- and post-treatment tumour samples.
To investigate the molecular signatures associated with metformin response
Comparison of gene expression in pre-metformin biopsy samples and post-metformin resected tumour samples. Expression of altered genes to be validated by IHC in tumour sections.
Measured: 6 months
Plasma ctDNA, measured as percentage of mutant to total DNA fragments in plasma
To assess the presence of ctDNA in resectable PDAC, and dynamic changes following treatment with metformin and surgical resection
Proportion of patients with detectable plasma ctDNA at baseline. Comparison of values pre- and post-metformin and 4-10 weeks after surgery.
Measured: 6 months
Correlation between imaging and pathologic parameters
To explore the correlation between apparent diffusion coefficient (ADC) on MRI and pathologic findings.
ADC values will be individually compared to tumour differentiation and Ki-67 fraction on pathologic examination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJan 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (51)Papers the sponsor has linked to this study.
- Other trials for Resectable Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Pancreatic Cancer Canada, BC Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Daniel J Renouf, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978547
- Sponsor's protocol ID
- H16-02566
- Acronym
- Metformin 001
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society. 2015.
Garcea G, Dennison AR, Pattenden CJ, Neal CP, Sutton CD, Berry DP. Survival following curative resection for pancreatic ductal adenocarcinoma. A systematic review of the literature. JOP. 2008 Mar 8;9(2):99-132.
PubMed 18326920AJCC Cancer Staging Manual. 7th ed. New York: Springer-Verlag; 2010.
Callery MP, Chang KJ, Fishman EK, Talamonti MS, William Traverso L, Linehan DC. Pretreatment assessment of resectable and borderline resectable pancreatic cancer: expert consensus statement. Ann Surg Oncol. 2009 Jul;16(7):1727-33. doi: 10.1245/s10434-009-0408-6. Epub 2009 Apr 24. No abstract available.
PubMed 19396496Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010 Apr 20;7(4):e1000267. doi: 10.1371/journal.pmed.1000267.
PubMed 20422030Palmer DH, Stocken DD, Hewitt H, Markham CE, Hassan AB, Johnson PJ, Buckels JA, Bramhall SR. A randomized phase 2 trial of neoadjuvant chemotherapy in resectable pancreatic cancer: gemcitabine alone versus gemcitabine combined with cisplatin. Ann Surg Oncol. 2007 Jul;14(7):2088-96. doi: 10.1245/s10434-007-9384-x. Epub 2007 Apr 24.
PubMed 17453298Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. doi: 10.1002/jso.21527.
PubMed 20461765Ben Sahra I, Le Marchand-Brustel Y, Tanti JF, Bost F. Metformin in cancer therapy: a new perspective for an old antidiabetic drug? Mol Cancer Ther. 2010 May;9(5):1092-9. doi: 10.1158/1535-7163.MCT-09-1186. Epub 2010 May 4.
PubMed 20442309Zhang P, Li H, Tan X, Chen L, Wang S. Association of metformin use with cancer incidence and mortality: a meta-analysis. Cancer Epidemiol. 2013 Jun;37(3):207-18. doi: 10.1016/j.canep.2012.12.009. Epub 2013 Jan 24.
PubMed 23352629Kourelis TV, Siegel RD. Metformin and cancer: new applications for an old drug. Med Oncol. 2012 Jun;29(2):1314-27. doi: 10.1007/s12032-011-9846-7. Epub 2011 Feb 8.
PubMed 21301998Coughlin SS, Calle EE, Teras LR, Petrelli J, Thun MJ. Diabetes mellitus as a predictor of cancer mortality in a large cohort of US adults. Am J Epidemiol. 2004 Jun 15;159(12):1160-7. doi: 10.1093/aje/kwh161.
PubMed 15191933Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.
PubMed 19029956Pannala R, Basu A, Petersen GM, Chari ST. New-onset diabetes: a potential clue to the early diagnosis of pancreatic cancer. Lancet Oncol. 2009 Jan;10(1):88-95. doi: 10.1016/S1470-2045(08)70337-1.
PubMed 19111249Appleman VA, Ahronian LG, Cai J, Klimstra DS, Lewis BC. KRAS(G12D)- and BRAF(V600E)-induced transformation of murine pancreatic epithelial cells requires MEK/ERK-stimulated IGF1R signaling. Mol Cancer Res. 2012 Sep;10(9):1228-39. doi: 10.1158/1541-7786.MCR-12-0340-T. Epub 2012 Aug 7.
PubMed 22871572Schaeffer DF, Owen DR, Lim HJ, Buczkowski AK, Chung SW, Scudamore CH, Huntsman DG, Ng SS, Owen DA. Insulin-like growth factor 2 mRNA binding protein 3 (IGF2BP3) overexpression in pancreatic ductal adenocarcinoma correlates with poor survival. BMC Cancer. 2010 Feb 23;10:59. doi: 10.1186/1471-2407-10-59.
PubMed 20178612
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neoadjuvant Metformin on Tumour Cell Proliferation and Tumour Progression in Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02978547
- Acronym / sponsor ID
- Metformin 001 / H16-02566
- Keywords
- Resectable pancreatic ductal adenocarcinoma, PDAC, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Pancreatic Cancer Canada, BC Cancer Foundation
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, non-randomized phase II study of neoadjuvant metformin in resectable PDAC. Twenty patients will be enrolled and treated with metformin 500 mg BD for a minimum of 7 days, until 2 days prior to surgery. Patients will undergo laboratory investigations at baseline, prior to surgery and 4-10 weeks after surgery. Patients eligible for and consented to the optional MRI substudy will undergo diffusion-weighted MRI 1 to 14 days before surgery.
At surgery, resected tumour and normal tissue will be collected and banked. FFPE specimens will be used for sectioning, histological analysis and IHC for Ki67 (cell proliferation marker), pAMPK, ACC targets, p53 and mTOR targets, apoptotic markers (Bax, Bcl-2, caspases 3, 8 and 9). Fresh frozen tumour and matched normal tissue samples will be used for western blot analysis of insulin and IGF receptors, total and activated ERK and Akt, and RNAseq analysis. Pre-metformin biopsy samples will be retrieved for molecular analysis.
Fasting blood samples at baseline and before surgery will be analyzed for glucose and insulin levels. Plasma and whole blood will also be processed and banked for circulating tumour DNA analysis. Urine samples will be sent for metabolomic profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin Hydrochloride 500Mg TabletAll patients will receive metformin 500 mg per oral twice daily with food for at least 7 days, until 2 days prior to surgery. Metformin therapy should be discontinued 2 days before surgery to reduce the risk of lactic acidosis associated with fasting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age greater than or equal to 18 years on the day of study consent
- Pathologic diagnosis of PDAC where 2 pre-treatment core biopsy samples are available for analysis. Patients with suspected PDAC without a pathologic diagnosis must undergo confirmatory biopsy under endoscopic ultrasound guidance.
- Resectable disease based on standard imaging criteria
- Surgery planned ≥ 2 weeks after study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (5 listed)
- Presence of locally unresectable disease or distant metastases
- Treatment with metformin or any other anti-hyperglycemic agent within the previous 6 months
- Known allergy or contraindication to metformin
- Not fit for surgery
- Planned for, or received, neoadjuvant treatment of any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Hydrochloride 500Mg TabletIn the event of any grade 2 toxicities (with the exception of hyperglycemia), metformin will be withheld until improvement to ≤ grade 1, then restarted at a dose of 500 mg daily. In the event of grade ≥ 3 toxicities related to metformin, treatment will be discontinued. Metformin therapy will also be discontinued if serum lactate levels are above normal values. | Drug | Metformin |
Primary outcome
The effect of neoadjuvant metformin treatment on tumour cell proliferation in PDAC tumours
Time frame: 6 months
Assessment of Ki-67 fraction as assessed by IHC of pre- and post-metformin tumour samples.
10 secondary outcomes
R0 resection rates in patients undergoing curative PDAC resection
Time frame: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting GGT (mmol/L)
Time frame: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting glucose (mmol/L)
Time frame: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, fasting insulin (mU/L)
Time frame: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by serum marker, HOMA index
Time frame: 6 months
The effect of metformin on glucose and insulin metabolism as assessed by clinical marker, weight (kg)
Time frame: 6 months
The effect of metformin on metabolomic profile of pre- and post-metformin samples
Time frame: 6 months
Transcriptome sequencing (RNAseq) of pre- and post-treatment tumour samples.
Time frame: 6 months
Plasma ctDNA, measured as percentage of mutant to total DNA fragments in plasma
Time frame: 6 months
Correlation between imaging and pathologic parameters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- BackgroundCanadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, ON: Canadian Cancer Society. 2015.
- Background: PubMed 18326920Garcea G, Dennison AR, Pattenden CJ, Neal CP, Sutton CD, Berry DP. Survival following curative resection for pancreatic ductal adenocarcinoma. A systematic review of the literature. JOP. 2008 Mar 8;9(2):99-132.
- BackgroundAJCC Cancer Staging Manual. 7th ed. New York: Springer-Verlag; 2010.
- Background: PubMed 19396496Callery MP, Chang KJ, Fishman EK, Talamonti MS, William Traverso L, Linehan DC. Pretreatment assessment of resectable and borderline resectable pancreatic cancer: expert consensus statement. Ann Surg Oncol. 2009 Jul;16(7):1727-33. doi: 10.1245/s10434-009-0408-6. Epub 2009 Apr 24. No abstract available.
- Background: PubMed 20422030Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010 Apr 20;7(4):e1000267. doi: 10.1371/journal.pmed.1000267.
- Background: PubMed 17453298Palmer DH, Stocken DD, Hewitt H, Markham CE, Hassan AB, Johnson PJ, Buckels JA, Bramhall SR. A randomized phase 2 trial of neoadjuvant chemotherapy in resectable pancreatic cancer: gemcitabine alone versus gemcitabine combined with cisplatin. Ann Surg Oncol. 2007 Jul;14(7):2088-96. doi: 10.1245/s10434-007-9384-x. Epub 2007 Apr 24.
- Background: PubMed 20461765Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. doi: 10.1002/jso.21527.
- Background: PubMed 20442309Ben Sahra I, Le Marchand-Brustel Y, Tanti JF, Bost F. Metformin in cancer therapy: a new perspective for an old antidiabetic drug? Mol Cancer Ther. 2010 May;9(5):1092-9. doi: 10.1158/1535-7163.MCT-09-1186. Epub 2010 May 4.
- Background: PubMed 23352629Zhang P, Li H, Tan X, Chen L, Wang S. Association of metformin use with cancer incidence and mortality: a meta-analysis. Cancer Epidemiol. 2013 Jun;37(3):207-18. doi: 10.1016/j.canep.2012.12.009. Epub 2013 Jan 24.
- Background: PubMed 21301998Kourelis TV, Siegel RD. Metformin and cancer: new applications for an old drug. Med Oncol. 2012 Jun;29(2):1314-27. doi: 10.1007/s12032-011-9846-7. Epub 2011 Feb 8.
- Background: PubMed 15191933Coughlin SS, Calle EE, Teras LR, Petrelli J, Thun MJ. Diabetes mellitus as a predictor of cancer mortality in a large cohort of US adults. Am J Epidemiol. 2004 Jun 15;159(12):1160-7. doi: 10.1093/aje/kwh161.
- Background: PubMed 19029956Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Renouf, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Hydrochloride 500Mg Tablet in people with Resectable Pancreatic Ductal Adenocarcinoma, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Renouf, MD (6048776000 ext. 2445, drenouf@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of neoadjuvant metformin treatment on tumour cell proliferation in PDAC tumours (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02978547, which also lists 51 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.